Menopausal Sleep Fragmentation and Body Fat Gain

NCT03047330 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 2016P0028211R01AG053838
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.

Conditions

Menopause

Keywords

menopause; sleep fragmentation; leuprolide; adipokine; weight gain; leptin

Outcome Measures

Primary Outcomes (1)

• Normalized Serum Leptin Levels

  12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).

  pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Secondary Outcomes (1)

• Normalized Satiety Scores

  pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)

Study Arms (1)

Study arm

EXPERIMENTAL

Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2).

Drug: Estradiol withdrawal; Other: Fragmented sleep

Interventions

Estradiol withdrawal DRUG

one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.

Also known as: Leuprolide Acetate; Lupron

Study arm

Fragmented sleep OTHER

Fragmented sleep will be experimentally induced.

Study arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy premenopausal women 18-45 years old
• Regular sleep schedule
• Limited alcohol and caffeine intake
• Regular monthly menstrual cycles
• No lifetime history of hot flashes
• Willingness to use approved methods of contraception during study
• Not obese
• Good general health

You may not qualify if:

• Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
• Pregnancy
• Breastfeeding
• Tobacco use
• Contraindicated systemic hormone medications or centrally active medications
• Shift workers or recent/expected time zone travel
• Obstructive sleep apnea
• Insomnia symptoms
• Diagnosis of osteoporosis or osteopenia
• Hypothalamic-pituitary-adrenal axis disorders
• Diabetes
• Gastric bypass, metabolic disorders, or other related conditions
• Abnormalities on screening laboratory tests
• Substantial hearing impairment
• Cardiovascular illness

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Weight Gain

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Body Weight Changes; Body Weight

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Hadine Joffe, MD MSc
• Organization: Brigham and Women's Hospital

hjoffe@bwh.harvard.edu

617-732-4906

Study Officials

• Hadine Joffe, MD MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 8, 2017
• Study Start: July 15, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

US (1)